Fucidin 250 mg/5 ml Oral Suspension

Fucidin is indicated in the treatment of all staphylococcal infections due to susceptible organisms such as: osteomyelitis, pneumonia, septicaemia, wound infections, endocarditis, superinfected cystic fibrosis, cutaneous infections.

Fucidin should be administered intravenously whenever oral therapy is inappropriate, which includes cases where absorption from the gastro-intestinal tract is unpredictable.

Posology

Each 5 ml of Fucidin Suspension is therapeutically equivalent to 175 mg of sodium fusidate owing to its lower oral bioavailability. Therefore the following dosages are recommended:

Since Fucidin is excreted in the bile, no dosage modifications are needed in renal impairment.

The dosage in patients undergoing haemodialysis needs no adjustment as Fucidin is not significantly dialysed.

Method of administration

For oral administration. The Suspension should be shaken well before use and dilution is not recommended.

Hypersensitivity to the active substance or to any of the excipients.

Statins (HMG-CoA reductase inhibitors) and systemic Fucidin must not be co-administered. There have been reports of rhabdomyolysis (including fatalities) in patients receiving this combination (see section 4.5). In patients where the use of systemic Fucidin is considered essential, statin treatment should be discontinued throughout the duration of treatment with systemic Fucidin. The patient should be advised to seek medical advice immediately if they experience any symptoms of muscle weakness, pain or tenderness. Statin therapy may be re-introduced seven days after the last dose of systemic Fucidin. In exceptional circumstances, where prolonged systemic Fucidin is needed, e.g. for the treatment of severe infections, the need for co-administration of HMG-CoA reductase inhibitors and systemic Fucidin should only be considered on a case by case basis and under close medical supervision.

In a few cases, serious cutaneous reactions putting life at risk such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, toxic epidermal necrolysis (Lyell's syndrome) and Stevens-Johnson syndrome have been reported with systemic Fucidin. Patients should be advised to monitor cutaneous reactions as well as signs and symptoms suggestive of these reactions which usually appear in the first weeks of therapy. If such reactions are suspected to be due to systemic Fucidin, treatment with systemic Fucidin should be stopped and it is recommended not to reintroduce the therapy.

Fusidic acid is metabolised in the liver and excreted in the bile. Elevated liver enzymes and jaundice have occurred during systemic Fucidin therapy but are usually reversible on discontinuation of the drug.

Systemic Fucidin should be given with caution and liver function should be monitored if used in patients with hepatic dysfunction or in patients taking potentially hepatotoxic drugs. Caution is required in patients with biliary disease and biliary tract obstruction. Caution is required in patients treated with HIV-protease inhibitors (See section 4.5). Fusidic acid competitively inhibits binding of bilirubin to albumin. Caution is necessary if systemic Fucidin is administered to patients with impaired transport and metabolism of bilirubin. Particular care is advised in neonates due to the theoretical risk of kernicterus.

Bacterial resistance has been reported to occur with the use of fusidic acid. As with all antibiotics, extended or recurrent use may increase the risk of developing antibiotic resistance.

Patients with rare hereditary problems of fructose intolerance should not take this medicine due to its content of sorbitol (E420).

Patients with rare glucose-galactose malabsorption should not take this medicine due to its content of glucose.

This medicinal product contains 1.05 mmol (24 mg) sodium per 15 ml (standard adult) dose equivalent to 1.2% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

This medicine contains 100 mg sorbitol per ml. The maximum dose is equivalent to 2.5 – 5.0 g/day. Sorbitol is a source of fructose. Patients with intolerance to some sugars or rare hereditary problems of fructose intolerance should not take this medicine due to its content of sorbitol (E420). Sorbitol may cause gastrointestinal discomfort and/or a mild laxative effect.

This medicine contains up to 7.5 µ g benzyl alcohol per ml. The maximum dose is equivalent to 94 to 375 µ g/day. Benzyl alcohol may cause allergic reactions.

The risk of myopathy including rhabdomyolysis may be increased by the concomitant administration of systemic Fucidin with statins. Co-administration of this combination may cause increased plasma concentrations of both agents. The mechanism of this interaction (whether it is pharmacodynamics or pharmacokinetic, or both) is yet unknown. There have been reports of rhabdomyolysis (including some fatalities) in patients receiving this combination. If treatment with Fucidin is necessary, statin treatment should be discontinued throughout the duration of the Fucidin treatment. Also see section 4.4.

Specific pathways of Fucidin metabolism in the liver are not known, however, an interaction between Fucidin and drugs being CYP-3A4 biotransformed can be suspected. The mechanism of this interaction is presumed to be a mutual inhibition of metabolism. There is insufficient data to characterise the effect of fusidic acid on CYPs in-vitro. The use of Fucidin systemically should be avoided in patients treated with CYP-3A4 biotransformed drugs.

Oral anticoagulants

Systemic Fucidin administered concomitantly with oral anticoagulants such as coumarin derivatives or anticoagulants with similar actions may increase the plasma concentration of these agents enhancing the anticoagulant effect. Anticoagulation should be closely monitored and a decrease of the oral anticoagulant dose may be necessary in order to maintain the desired level of anticoagulation. Similarly, discontinuation of Fucidin may require the maintenance dose of anticoagulant to be re-assessed. The mechanism of this suspected interaction remains unknown.

HIV protease inhibitors

Co-administration of systemic Fucidin and HIV protease inhibitors such as ritonavir and saquinavir may cause increased plasma concentrations of both agents which may result in hepatotoxicity.

Concomitant use is not recommended. (See section 4.4).

Pregnancy:

There are no or limited data (less than 300 pregnancy outcomes) from the use of fusidic acid in pregnant women. Animal studies do not indicate direct or indirect harmful effect with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of systemic Fucidin during pregnancy.

Breast-feeding:

Physico-chemical data suggest excretion of fusidic acid in human milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from systemic Fucidin therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Fertility

There are no clinical studies with systemic Fucidin regarding fertility. Pre-clinical studies did not show any effect of sodium fusidate on the fertility in rats.

Fucidin has no or negligible influence on the ability to drive or to use machines.

The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical trials and from spontaneous reporting.

The most frequently reported undesirable effects of Fucidin administered orally are gastrointestinal disorders like abdominal discomfort and pain, diarrhoea, dyspepsia, nausea and vomiting. Anaphylactic shock has been reported.

Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported. Within each frequency group, adverse reactions are presented in the order of decreasing seriousness.

Very common (≥ 1/10)

Common (≥ 1/100 to < 1/10)

Uncommon (≥ 1/1,000 to <1/100)

Rare (≥ 1/10,000 to <1/1,000)

Very rare (<1/10,000)

Not known (cannot be estimated from available data)

a) Haematological disorders affecting the white cell line (neutropenia, granulocytopenia and agranulocytosis) have been reported

b) Hepatitis also includes Hepatitis cholestatic /Cytolytic hepatitis

c) Jaundice also includes Jaundice cholestatic

d) Including alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased and gamma-glutamyltransferase increased

e) Rash includes various types of rash reactions such as drug eruption, erythematous and maculo-papular rash

f) These adverse reactions were identified through post-marketing surveillance. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency (see section 4.4)

g) Rhabdomyolysis may be fatal

h) Renal failure also includes renal failure acute

Paediatric population

Frequency, type and severity of adverse reactions in children are expected to be the same as in adults, based on limited data.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Acute symptoms of overdose include gastrointestinal disturbances. Management should be directed towards alleviation of symptoms. Dialysis will not increase the clearance of fusidic acid.

An overdose of 4 g/day for a duration of ten days in an adult has been reported without any adverse events.

An overdose of 1,250 mg/day for a duration of seven days in a child (three years old) has been reported without any adverse events.

Pharmacotherapeutic group: Steroid antibacterials, ATC code: J01XC01

Fusidic acid and its salts are potent anti-staphylococcal agents with unusual ability to penetrate tissue. Bactericidal levels have been assayed in bone and necrotic tissue. Concentrations of 0.03-0.12 mcg/ml inhibit nearly all strains of staphylococcus aureus. Fusidic acid is active against staphylococcus epidermidis and methicillin resistant staphylococci.

Blood levels are cumulative, reaching concentrations of 50-100 mcg/ml after oral administration of 1.5 g daily for 3 to 4 days.

Fucidin is excreted mainly in the bile, little or none being excreted in the urine.

In severe or deep-seated infections and when prolonged therapy may be required, systemic Fucidin should generally be given concurrently with other anti-staphylococcal antibiotic therapy.

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Acesulfame potassium

Banana flavour

Citric acid

Disodium phosphate dihydrate

Hydroxyethylcellulose

Glucose liquid

Methylcellulose

Orange dry flavour

Sodium benzoate (E211)

Sorbitol (E420)

Purified water.

Not applicable.

3 years.

After first opening: 28 days

This medicinal product does not require any special storage conditions.

Amber glass bottle with a white HDPE screw cap supplied with a measuring cup.

Pack sizes: 50 ml and 90 ml.

Not all pack sizes may be marketed.

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.